EPC Samedan Ltd. Pharmaceutical Publishers

Advert of CRS Group in electronical directory (350 words)

CRS is a full service CRO in phase I-IV. The holding comprises three Phase I subsidiaries, CRS-Kiel, CRS-Moenchengladbach and CRS-Mannheim. Each unit has between 15 and 30 years of experience in clinical trials Phase I - II. Additionally, the Mannheim/Gruenstadt unit is also engaged in the coordination of Phase III – IV trials, bioanalytics, medical writing, CDM & statistics.

Clinical Studies Phase I-IIa

With 195 beds in total, CRS is one of the top three CROs in Europe. Additionally, the units provide capabilities for ambulatory trial designs. Supplementary to standard human pharmacology work in Phase I, CRS offers clinical trials in renal and hepatic impaired patients, Thorough QTc trials with various central ECG labs and additional assessments of PD parameters in CNS, gastrointestinal research, and pneumology.

Clinical Studies Phase III-IV

CRS offers full service for Phase II-III multicentre trials: Project management, site selection, regulatory submission, study logistics, site staff training and monitoring.

Further services are:

•          Product & disease registries

•          Patient reported outcomes

•          Non-Interventional studies

•          Phase IV studies

Bioanalytics

GLP certified in 1992 and FDA inspected (1991 and 2002). Within  more than 30 years, more than 300 analytical methods  developed and validated. The analytical equipment complies with international standards.

CTSM and IMPs

CRS is equipped to handle IMPs. Staffed with qualified persons according to §14 AMG (German Drug Law), GMP certified and manufacturing licensed.

Clinical Datamanagement

Study planning

• Statistical trial planning

• CRF design,

• Randomization

• Design of data structures  

Study conduct

• Database set-up,

Data entry with Oracle Clinical

• Data transfer from third parties

•  Data validation (validation plan, programming

in SAS or Oracle Clinical)

• Query management, study coordination

• Medical coding

 Biometrica/PK-evaluation

Medical Writing–

Study protocols and integrated reports according to ICH.  IBs, PSURs  publications, lectures, posters, pharmacological/toxicological reports and clinical expert reports. All systems of Clinical Data Management are validated according to 21 CFR part 11.

Quality Assurance

QA is centrally organised for the whole CRS Group. The department is responsible for performing audits during clinical and bioanalytical studies according to GCP, GLP, GMP and the respective legal requirements.